17/09/2021
Get the lowdown on traditional medicines and OTC products in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are ruled through Decree 2266/04 which establishes regulatory requirements for phytotherapeutics. These are some of their main requirements: Pharmaceutical forms: tisanes or any…
08/09/2021
Want to know more about traditional medicines and OTC products in Portugal? Read on! Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary, or alternative medicines are subject to a registration procedure before Infarmed. The registration procedure may be national, based on a…
30/08/2021
A legal intro to traditional medicines and OTC products in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional Chinese Medicine (“TCM”) is a system for diagnosis, prevention and treatment that has existed for thousands of years and is…
23/07/2021
The ins and outs of traditional medicines and OTC products in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products and homeopathic medicinal products are subject to specific regulation set out in the Act on Drugs. Traditional…
10/07/2021
A brief overview of the situation regarding traditional medicines and OTC products in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are treated as nutrition products (dietary products or health supplements, as the case may be) under Russian law. Thus, the basic…
27/04/2021
The ins and outs of traditional medicines and OTC products in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? As per Article 1 of the Pharmacy Law of 1983, medicines are defined as “any medicine that contains one or more element…
20/04/2021
The legal framework for traditional medicines and OTC products in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Pharmaceutical Law provides for a simplified procedure for the marketing authorization of herbal medicinal products, provided that they meet criteria for traditional herbal…
30/05/2020
Want to know more about traditional medicines and OTC products in Vietnamese Pharma? Read on! Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Law on Pharmacy and its implementing regulations are equally applicable to modern drugs and traditional and herbal drugs.…
29/05/2020
Traditional medicines and OTC products in Venezuelan Pharma – a comprehensive legal overview. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Constitution of Venezuela recognizes the practice of traditional medicine in indigenous peoples and communities. Alternative medicine is not…
28/05/2020
An intro to the legal situation for traditional medicines and OTC products in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The distribution of alternative medicinal products such as traditional, herbal or complementary medicines requires a marketing authorisation. Such authorisation is…
27/05/2020
Key legal info on traditional medicines and OTC products in Norwegian Pharma. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Medicines Act (LOV-1992-12-04-132) provides for any procedure for the MA of traditional medicines, including herbal and homeopathic medicines, whilst the Medical Devices…
04/02/2020
The ins and outs of traditional medicines and OTC products in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices as per the Medicines and Allied Substances Control (Complementary Medicines)…
03/02/2020
An insight into traditional medicines and OTC products in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary or alternative medicines and devices on the Irish market must be either authorised or registered with the HPRA which, as…
23/01/2020
The ins and outs of traditional medicines and OTC products in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? a. Herbal Medicinal Products The Italian Medicines Code provides for an abridged procedure for the marketing authorization of herbal medicinal products, provided that: they are intended…
22/01/2020
A brief overview of the situation regarding traditional medicines and OTC products in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Law of 25 March 1964 on the medicines distinguishes between homeopathic medicines, traditional herbal medicines and herbal medicines. All three categories are subject to…
19/01/2020
All legal aspects surrounding traditional medicines and OTC products in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal and complementary products are commonly regulated by Ministry of Commerce under provisions of Consumer Protection and Fraud Repression Law No 09-03 dated…
11/11/2019
The legal framework for traditional medicines and OTC products in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? No specific definition of complementary and alternative medicines (CAMs) is used in the UK, though “complementary” would typically refer to a CAM when…
09/11/2019
All legal aspects surrounding traditional medicines and OTC products in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In April 2019, the Thai FDA published and implemented the Herbal Product Act. This is now the main act regulating herbal or traditional medicine in…
06/11/2019
The low-down on the situation regarding traditional medicines and OTC products in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Herbal medicines and related products are products that contain exclusively active ingredients of one or more herbal substances or one or more herbal…
08/10/2019
A brief overview of the situation regarding traditional medicines and OTC products in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Alternative medicine is regulated by the Traditional and Complementary Medicine Council (“TCM Council”) established under the Traditional and Complementary Medicine Act 2016 (“TCMA…
23/08/2019
The key facts about traditional medicines and OTC products in Bulgarian Pharma. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Bulgarian law regulates medicinal products and medical devices differently. Medicinal products are grouped in three categories: (i) conventional medicinal products; (ii) traditional herbal medicinal products; and (iii) homeopathic…
09/08/2019
A brief overview of the situation regarding traditional medicines and OTC products in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary, or alternative medicines and devices are subject to the PMD Act. 2. Can these traditional, herbal, complementary, or…
18/07/2019
A brief overview of the situation regarding traditional medicines and OTC products in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Plants traditionally used in Spain for medicinal purposes can be sold to the public without the need for a marketing authorization issued…
17/07/2019
Key legal info on traditional medicines and OTC products in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Natural medicinal products, traditional herbal medicinal products, homeopathic medicinal products, and strong vitamin and mineral products are all special categories of medicinal products and are as…
02/07/2019
An insight into traditional medicines and OTC products in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Find attach a document with drugs Requirements. Find attachment document with Device Requirements. 2. Can these traditional, herbal, complementary, or alternative products be advertised directly to…
The low-down on the situation regarding traditional medicines and OTC products in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products and homeopathic medicinal products are regulated by the Act on Medicinal Products and its regulations. Traditional herbal medicinal products may receive…
30/06/2019
The key facts about traditional medicines and OTC products in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Health Law transposed into the national legislation the provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use, and provides…
A brief overview of the situation regarding traditional medicines and OTC products in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The requirements for traditional, herbal, complementary, or alternative medicines and devices that have therapeutically property are the same as for drugs. Please see Question 1…
29/06/2019
All about traditional medicines and OTC products in Luxembourg. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? According to article 52-2 of Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, traditional herbal medicinal products which meet the following requirements are registered…
Key legal info on traditional medicines and OTC products in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative drugs and devices? Traditional drugs are mainly regulated under MOH Regulation No. 006 of 2016 on Traditional Drugs Industries and Business (“MOH Regulation 006”) and MOH Regulation No. 007…
28/06/2019
The low-down on the situation regarding traditional medicines and OTC products in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Medicinal Products Act contains special regulations governing Traditional Herbal Medicines and Homoeopathic Medicinal Products: 1. As per secc. 39a et…
A brief overview of the situation regarding traditional medicines and OTC products in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The regulatory requirements for traditional and herbal products shall follow the regulations and standards: WHO requirements and guidelines; Good Manufacturing…
27/06/2019
All about traditional medicines and OTC products in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Regulatory requirements for traditional herbal or homeopathic medicinal products are regulated by the provisions of Medicinal Products Act and traditional herbal medicinal products are also regulated by…
26/06/2019
An intro to the legal situation for traditional products and OTC medicines in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In Chile, Traditional Herbal Medicines shall be understood as those constituted by plants or parts of plants, fresh or dried, whole or crushed,…
01/03/2019
Want to know more about traditional medicines and OTC products in Singapore? Read on! Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Chinese proprietary medicines, traditional (Indian and Malay) medicines, homeopathic medicines and medicated oils and balms are regulated under the Medicines Act (Chapter 176), the Medicines (Advertisement and…
15/02/2019
The ins and outs of traditional medicines and OTC products in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Legal provisions pertaining to the regulatory requirements of the various types of medicinal products and medical devices may be found in various Interministerial Decisions and…
12/02/2019
Bolivian regulation regarding traditional medicines and OTC products. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Products must contain vegetal, mineral or animal components in order for them to be classified as “traditional, herbal, complementary or alternative medicines”. 2. Can these traditional, herbal, complementary, or…
08/02/2019
The ins and outs of the legal requirements for traditional medicines and OTC medicines in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Storage, Commercialization, importation, distribution require, with the exception of alternative medicine, a Sanitary Registration for each product. 2. Can these traditional, herbal,…
28/01/2019
An intro to the legal situation for traditional products and OTC medicines in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In Canada, traditional, herbal, complementary or alternative medicines are included under the previously defined term “NHPs.” NHPs are governed by the Food and Drugs Act and the Natural…
23/01/2019
A guide to the state-of-play regarding traditional medicines and over-the-counter (OTC) products in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Resolution RDC No. 26/2014 provides for traditional and herbal drugs requirements. These drugs are subject to registration, simplified registration…
08/11/2018
The ins and out of traditional medicines and OTC products in Lithuania. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products are regulated by the Law of the Republic of Lithuania on Pharmacy and its regulations. Traditional herbal medicinal products may receive…
All you need to know about traditional medicines and OTC products in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products are regulated by the PL and its regulations. Traditional herbal medicinal products may receive a marketing authorization following a…
07/11/2018
Traditional medicines and OTC products in Estonia – a comprehensive legal overview. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Primary legislation for herbal medicines and traditional herbal medicines is the Medicinal Products Act and its regulations. Marketing of herbal medicines requires a marketing…
06/11/2018
The key facts about traditional medicines and OTC products in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Regarding medicines and devices please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview. Decrees 403/016 and 404/016 state that any company undertaking operations with herbal…
The lowdown on the situation regarding traditional medicines and OTC products in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products are pharmaceutical preparations which have specific indications for use, which are specifically administered according to the specified dose and posology,…
26/10/2018
A brief overview of the situation regarding traditional medicines and OTC products in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Ukrainian legislation distinguishes between traditional and herbal medicines; furthermore, homeopathic preparations are as well recognized as medicines in Ukraine. There is no…
12/10/2018
Traditional medicines & OTC products in South Africa – a legal guide. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In terms of the Medicines Act medication is classified into 4 categories from Category A- Category D depending on the In terms of the…
11/10/2018
A guide to the legal requirements for traditional medicines and OTC products in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are categorized under the D&C Act broadly into Ayurveda, Siddha and Unani (“ASU”) drugs and Homoeopathic medicines. Ayurveda, Siddha…
29/08/2018
Need info on traditional medicine and OTC products in Ecuador? Read on! Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, complementary or alternative medicines are governed by the General Health Law (HL) and its regulations. These medicines are known as natural, whose active ingredients are…
09/08/2018
The environment surrounding traditional and OTC products in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Herbal and vegetable medicines are regulated by ANMAT. They are defined as medicine that contains as an active ingredient one or more plant medicines, or one or…
25/10/2016
The key points to know from a legal standpoint about traditional medicines and OTC products in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products are regulated by the General Health Law and its regulations. This type of products can contain…
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